Hydrocortisone Butyrate 1 mg/mL Solution — NDC 51672-4061-4 (Billing 51672-4061-04)
This is a package of Hydrocortisone Butyrate 1 mg/mL Solution from Sun Pharmaceutical Industries, Inc., marketed since Jan 2004 and currently FDA-listed; retail pharmacies pay about $2.18 per mL (NADAC). It is the main listing for this product, which comes in 2 package sizes.
NDC database record
One package, one record: these facts belong to NDC 51672-4061-4 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 51672 labeler · 4061 product · 4 package
- Package marketed since
- Jan 14, 2004
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2027
- Barcode (UPC-A, from the NDC)
- 3 5167240614 1
- Medicaid fills, this package
- 38,631 prescriptions in the last four reported quarters
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 016897
- GCN: 48811
- HICL (First Databank): 003297
- AHFS class code: 52:08.08.00
- RxCUI (RxNorm): 1370758
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
RxNorm drug class
This medicine belongs to the Corticosteroid class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
- It calms redness, swelling and itching from skin conditions that respond to steroids. Hydrocortisone Butyrate Cream (lipid), 0.1% is used in adults for those conditions. It is also...
- Apply it to your skin exactly as your prescriber and the label direct. In the studies it was used twice a day for mild to moderate eczema. Keep it out of your eyes, and don't cover...
- Most are mild and happen where you apply it. These include irritation, burning, itching, dryness, acne or inflamed hair follicles. With longer use, skin thinning or stretch marks c...
- Call if you notice blurred vision or other eye changes, if your skin looks infected, or if the rash gets worse or won't heal. Also call about signs the steroid is affecting your wh...
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $2.176 | $130.58 / 60 ml |
| Medicaid paysCMS SDUD · 12 mo | $3.85 | $230.83 / 60 ml |
| Medicare drug plans payPart D · Q2 2026 | $2.23 | $133.90 / 60 ml |
Where does this data come from?
- CMS NADAC weekly file · file of Oct 7, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Marketing end | Status |
|---|---|---|---|---|---|---|
| 51672-4061-02 51672-4061-2 | 1 BOTTLE in 1 CARTON / 20 mL in 1 BOTTLE | — | — | 2004-01-14 | — | Active |
| 51672-4061-04 You're viewing this Main listing | 1 BOTTLE in 1 CARTON / 60 mL in 1 BOTTLE | $2.18 / mL | $130.59 | 2004-01-14 | — | Active |
In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in this package?
What NDC number is used to bill for this package of Hydrocortisone Butyrate 1 mg/mL Solution?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Hydrocortisone Butyrate 1 mg/mLthis 51672-4061-04 | Sun | 1 bottle | $2.176 | AT | Availability likely | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Oct 7, 2026
Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
🧪 Avoiding an ingredient? See Hydrocortisone Topical inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 2968PHW8QP
A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
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UNII PDC6A3C0OX
Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
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UNII ND2M416302
Isopropyl alcohol is a clear liquid solvent derived from petroleum. In medicines, it dissolves active ingredients and other components, helps the product flow smoothly, and aids in sterilization during manufacturing.
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UNII FZ989GH94E
Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
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UNII B22547B95K
A salt derived from citric acid that helps maintain the proper acid-base balance in the medicine. It's used as a buffer to keep the product stable and at the right pH level.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
6 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 6, 2026
- FDA openFDA NDC Directory · synced Oct 8, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Sun Pharmaceutical Industries, Inc. labeler code 51672
- Etodolac 500 mg Tablet, Extended Release NDC 51672-4052-1
- Etodolac 600 mg Tablet, Extended Release NDC 51672-4053-1
- Amiodarone Hydrochloride 100 mg Tablet NDC 51672-4055-6
- Amiodarone Hydrochloride 300 mg Tablet NDC 51672-4056-0
- Amiodarone Hydrochloride 400 mg Tablet NDC 51672-4057-0
- Amcinonide 1 mg/g Ointment NDC 51672-4060-1
- Fluorouracil 20 mg/mL Solution NDC 51672-4062-1
- Fluorouracil 50 mg/mL Solution NDC 51672-4063-1
- Phenytoin 125 mg/5mL Suspension NDC 51672-4069-1
- Cetirizine Hydrochloride 1 mg/mL Solution NDC 51672-4070-8
- Hydrocortisone Butyrate 1 mg/g Cream NDC 51672-4074-1
- Desonide .5 mg/mL Lotion NDC 51672-4079-4
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Hydrocortisone Butyrate Ointment, 0.1% and Hydrocortisone Butyrate Cream USP, 0.1% are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Hydrocortisone Butyrate Topical Solution, 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of seborrheic dermatitis.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Hydrocortisone Butyrate Ointment, 0.1% or Hydrocortisone Butyrate Cream USP, 0.1% should be applied to the affected area as a thin film two or three times daily depending on the severity of the condition. Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions. If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.
Hydrocortisone Butyrate Topical Solution, 0.1% should be applied to the affected area as a thin film two or three times daily depending on the severity of the condition.
⛔ Contraindications ▾
CONTRAINDICATIONS None.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS The following local adverse reactions are reported infrequently with topical corticosteroids but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae and miliaria.
🤰 Pregnancy ▾
Pregnancy Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids.
Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time. Systemic embryofetal development studies were conducted in rats and rabbits.
Subcutaneous doses of 0.6, 1.8 and 5.4 mg/kg/day hydrocortisone butyrate were administered to pregnant female rats during gestation days 6 – 17. In the presence of maternal toxicity, fetal effects noted at 5.4 mg/kg/day (2× MTHD) included an increased incidence of ossification variations and unossified sternebra. No treatment-related effects on embryofetal toxicity or teratogenicity were noted at doses of 5.4 and 1.8 mg/kg/day, respectively (2× MTHD and 0.7× MTHD, respectively).
Subcutaneous doses of 0.1, 0.2 and 0.3 mg/kg/day hydrocortisone butyrate were administered to pregnant female rabbits during gestation days 7 – 20. An increased incidence of abortion was noted at 0.3 mg/kg/day (0.2× MTHD). In the absence of maternal toxicity, a dose-dependent decrease in fetal body weight was noted at doses ≥0.1 mg/kg/day (0.1× MTHD).
Additional indicators of embryofetal toxicity (reduction in litter size, decreased number of viable fetuses, increased post-implantation loss) were noted at doses ≥0.2 mg/kg/day (0.2× MTHD). Additional fetal effects noted in this study included delayed ossification noted at doses ≥0.1 mg/kg/day and an increased incidence of fetal malformations (primarily skeletal malformations) noted at doses ≥0.2 mg/kg/day. A dose at which no treatment-related effects on embryofetal toxicity or teratogenicity were observed was not established in this study.
Additional systemic embryofetal development studies were conducted in rats and mice. Subcutaneous doses of 0.1 and 9 mg/kg/day hydrocortisone butyrate were administered to pregnant female rats during gestation days 9 – 15. In the presence of maternal toxicity, an increase in fetal deaths and fetal resorptions and an increase in the number of ossifications in caudal vertebrae were noted at a dose of 9 mg/kg/day (3× MTHD).
No treatment-related effects on embryofetal toxicity or teratogenicity were noted at 0.1 mg/kg/day (0.1× MTHD). Subcutaneous doses of 0.2 and 1 mg/kg/day hydrocortisone butyrate were administered to pregnant female mice during gestation days 7 – 13. In the absence of maternal toxicity, an increased number of cervical ribs and one fetus with clubbed legs were noted at a dose of 1 mg/kg/day (0.2× MTHD).
No treatment-related effects on embryofetal toxicity or teratogenicity were noted at doses of 1 and 0.2 mg/kg/day, respectively (0.2× MTHD and 0.1× MTHD, respectively). No topical embryofetal development studies were conducted with hydrocortisone butyrate cream and hydrocortisone butyrate topical solution. However, topical embryofetal development studies were conducted in rats and rabbits with a hydrocortisone butyrate ointment formulation.
Topical doses of 1% and 10% hydrocortisone butyrate ointment were administered to pregnant female rats during gestation days 6 – 15 or pregnant female rabbits during gestation days 6 – 18. A dose-dependent increase in fetal resorptions was noted in rabbits (0.2 – 2× MTHD) and fetal resorptions were noted in rats at the 10% hydrocortisone butyrate ointment dose (80× MTHD). No treatment-related effects on embryofetal toxicity were noted at the 1% hydrocortisone butyrate ointment dose in rats (8× MTHD).
A dose at which no treatment-related effects on embryofetal toxicity were observed in rabbits after topical… [Excerpted — this section continues on DailyMed.]
🧒 Pediatric Use ▾
Pediatric Use Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio. Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels and absence of response to ACTH stimulation.
Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. Administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Topical corticosteroids share anti-inflammatory, anti-pruritic and vasoconstrictive actions. The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids.
There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man. Pharmacokinetics The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings. Topical corticosteroids can be absorbed from normal intact skin.
Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids.
Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Hydrocortisone Butyrate Ointment, 0.1% is supplied in tubes containing: 5 g NDC 51672-4083-5 (as physician samples) 10 g NDC 51672-4083-7 15 g NDC 51672-4083-1 30 g NDC 51672-4083-2 45 g NDC 51672-4083-6 Hydrocortisone Butyrate Cream USP, 0.1% is supplied in tubes containing: 5 g NDC 51672-4074-5 (as physician samples) 10 g NDC 51672-4074-7 15 g NDC 51672-4074-1 30 g NDC 51672-4074-2 45 g NDC 51672-4074-6 Hydrocortisone Butyrate Topical Solution, 0.1% is supplied in polyethylene bottles containing: 20 mL NDC 51672-4061-2 60 mL NDC 51672-4061-4 STORAGE Hydrocortisone Butyrate Ointment, 0.1%: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Hydrocortisone Butyrate Cream USP, 0.1%: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Hydrocortisone Butyrate Topical Solution, 0.1%: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
📦 Storage and Handling ▾
STORAGE Hydrocortisone Butyrate Ointment, 0.1%: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Hydrocortisone Butyrate Cream USP, 0.1%: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Hydrocortisone Butyrate Topical Solution, 0.1%: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
📋 Description ▾
DESCRIPTION Hydrocortisone Butyrate Ointment, Cream and Topical Solution contain the topical corticosteroid, hydrocortisone butyrate, a non-fluorinated hydrocortisone ester. It has the chemical name: 11β,17,21-Trihydroxypregn-4-ene-3,20-dione 17-butyrate; the molecular formula: C 25 H 36 O 6 ; the molecular weight: 432.54; and the CAS registry number: 13609-67-1. Its structural formula is: Chemical Structure Hydrocortisone Butyrate Ointment, 0.1% Each gram of hydrocortisone butyrate ointment contains 1 mg of hydrocortisone butyrate in a base consisting of mineral oil and polyethylene.
Hydrocortisone Butyrate Cream USP, 0.1% Each gram of hydrocortisone butyrate cream contains 1 mg of hydrocortisone butyrate in a hydrophilic base consisting of anhydrous citric acid, cetomacrogol 1000, cetostearyl alcohol, light mineral oil, propylparaben and butylparaben (preservatives), purified water, sodium citrate anhydrous and white petrolatum. Hydrocortisone Butyrate Topical Solution, 0.1% Each mL of hydrocortisone butyrate topical solution contains 1 mg of hydrocortisone butyrate in a vehicle consisting of citric acid monohydrate, glycerin, isopropyl alcohol (50% v/v), povidone, purified water and sodium citrate.
💬 Information for Patients ▾
Information for Patients Patients using topical corticosteroids should receive the following information and instructions: This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.
Patients should be advised not to use this medication for any disorder other than that for which it was prescribed. The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician. Patients should report any signs of local adverse reactions especially under occlusive dressing.
Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings.
⚠️ Precautions ▾
PRECAUTIONS General Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients. Conditions which augment systemic absorption include the application of the more potent corticosteroids, use over large surface areas, prolonged use, and the addition of occlusive dressings. Therefore, patients receiving a large dose of a potent topical corticosteroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by using ACTH stimulation tests.
If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent corticosteroid. Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of corticosteroid withdrawal may occur, requiring supplemental systemic corticosteroids.
Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity. (See PRECAUTIONS – Pediatric Use ). If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted.
In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled. Information for Patients Patients using topical corticosteroids should receive the following information and instructions: This medication is to be used as directed by the physician.
It is for external use only. Avoid contact with the eyes. Patients should be advised not to use this medication for any disorder other than that for which it was prescribed.
The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician. Patients should report any signs of local adverse reactions especially under occlusive dressing. Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings.
Carcinogenesis, Mutagenesis, and Impairment of Fertility Note: The animal multiples of human exposure calculations in this label were based on body surface area comparisons for an adult (i.e., mg/m 2 /day dose comparisons) assuming 100% human percutaneous absorption of a maximum topical human dose (MTHD) for hydrocortisone butyrate cream, ointment and topical solution (25 g). In a 2-year dermal rat carcinogenicity study with hydrocortisone butyrate lotion, hydrocortisone butyrate was administered to Sprague-Dawley rats at topical doses of 0.05, 0.15, and 0.3 mg/kg/day in males and 0.1, 0.25, and 0.5 mg/kg/day in females (0.1% lotion).
No drug-related tumors were noted in this study up to the highest doses evaluated in this study of 0.3 mg/kg/day in males (0.1× MTHD) and 0.5 mg/kg/day in females (0.2× MTHD). Hydrocortisone butyrate revealed no evidence of mutagenic or clastogenic potential based on the results of two in vitro genotoxicity tests (Ames test and L5178Y/TK +/- mouse lymphoma assay) and one in vivo genotoxicity test (mouse micronucleus assay). No evidence of impairment of fertility or effect on mating performance was observed in a fertility and general reproductive performance study conducted in male and female rats at subcutaneous doses up to and including 1.8 mg/kg/day (0.7× MTHD).
Mild effects on maternal animals, such as reduced food consumption and a subsequent reduction in body weight gain, were seen at doses ≥0.6 mg/kg/day (0.2× MTHD). Pregnancy Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The mo… [Excerpted — this section continues on DailyMed.]
🍼 Nursing Mothers ▾
Nursing Mothers It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk, in quantities not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman.
🧬 Pharmacokinetics ▾
Pharmacokinetics The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption.
Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees.
Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
Carcinogenesis, Mutagenesis, and Impairment of Fertility Note: The animal multiples of human exposure calculations in this label were based on body surface area comparisons for an adult (i.e., mg/m 2 /day dose comparisons) assuming 100% human percutaneous absorption of a maximum topical human dose (MTHD) for hydrocortisone butyrate cream, ointment and topical solution (25 g). In a 2-year dermal rat carcinogenicity study with hydrocortisone butyrate lotion, hydrocortisone butyrate was administered to Sprague-Dawley rats at topical doses of 0.05, 0.15, and 0.3 mg/kg/day in males and 0.1, 0.25, and 0.5 mg/kg/day in females (0.1% lotion).
No drug-related tumors were noted in this study up to the highest doses evaluated in this study of 0.3 mg/kg/day in males (0.1× MTHD) and 0.5 mg/kg/day in females (0.2× MTHD). Hydrocortisone butyrate revealed no evidence of mutagenic or clastogenic potential based on the results of two in vitro genotoxicity tests (Ames test and L5178Y/TK +/- mouse lymphoma assay) and one in vivo genotoxicity test (mouse micronucleus assay). No evidence of impairment of fertility or effect on mating performance was observed in a fertility and general reproductive performance study conducted in male and female rats at subcutaneous doses up to and including 1.8 mg/kg/day (0.7× MTHD).
Mild effects on maternal animals, such as reduced food consumption and a subsequent reduction in body weight gain, were seen at doses ≥0.6 mg/kg/day (0.2× MTHD).
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL - 20 mL Bottle Carton 20 mL NDC 51672-4061-2 Hydrocortisone Butyrate Topical Solution 0.1% NOT FOR OPHTHALMIC USE. FOR TOPICAL USE ONLY. Rx only TARO PRINCIPAL DISPLAY PANEL - 20 mL Bottle Carton
PRINCIPAL DISPLAY PANEL - 15 g Tube Carton - Cream NDC 51672-4074-1 15 g Hydrocortisone Butyrate Cream USP, 0.1% FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE. Rx only Keep this and all medications out of the reach of children. TARO PRINCIPAL DISPLAY PANEL - 15 g Tube Carton - Cream
PRINCIPAL DISPLAY PANEL - 15 g Tube Carton - Ointment NDC 51672-4083-1 15 g Hydrocortisone Butyrate Ointment 0.1% FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE. Rx only Keep this and all medications out of the reach of children. TARO PRINCIPAL DISPLAY PANEL - 15 g Tube Carton - Ointment